Herbal/organic composition for the management of pain

ABSTRACT

An herbal/organic composition for the treatment and management of pain contains about 0.01 wgt %  Boswellia  extract, about 0.01 wgt % ginger extract, about 0.01 wgt % holy basil extract, about 0.01 wgt % rosemary extract, about 0.01 wgt % turmeric extract, about 0.01 wgt % white willow extract, about 0.01 wgt % alpha lipoic acid and about 10.0 wgt % trolamine salicylate and about 89.93 wgt % of a carrier such as water. The composition is applied to an around an area of pain two or three times a day for seven to 14 days.

FIELD OF THE INVENTION

This invention relates to an herbal/organic composition for themanagement of pain and methods utilizing such compositions for thetreatment and management of pain in human patients.

BACKGROUND FOR THE INVENTION

In an earlier application filed by Applicant, U.S. patent applicationSer. No. 13/036,514 filed on Feb. 28, 2011 and claiming the priority ofa U.S. Provisional Application No. 61/388,995, filed Oct. 1, 2010,entitled Compositions and Methods for Treatment and Management of Pain,Applicant discloses an improved composition and method for treatment andmanagement of pain in human patients. The present invention represents afurther improvement over my earlier patent application.

In my earlier application, I disclosed and claimed an herbal compositionfor the management of pain comprising turmeric extract, Boswelliaextract, ginger extract, holy basil extract, rosemary extract, whitewillow extract and alpha lipoic acid.

In a preferred embodiment of the present invention, the herbal organiccomposition for the management of pain includes the following turmericextract, Boswellia extract, ginger extract, holy basil extract, rosemaryextract, white willow extract and alpha lipoic acid in equal amounts arepresent in an amount of about 0.01% by wgt. while the trolaminesalicylate is present in the amount of 10% by wgt. Further, apharmaceutical acceptable carrier is selected from the group consistingof water, glycerol stearate, octinoxate, alphotocapherol (vitamin E),diazolidimylurea, Coco Caprylate/Caprate and Sterearyl Stearate.

Accordingly, there remains a need for easy-to-use formulations havinganalgesic and/or anti-inflammatory properties that can avoid thedrawbacks of the prior art analgesic products.

A number of U.S. Patents and Patent Application Publications disclosevarious herbal remedies for use in treating various ailments includingpain. For example, a U.S. Patent Application Publication of Rosenbloom,No. 2003/0031737 discloses a medicinal composition and method of usingit. The composition is used to treat the symptoms of the common cold, asore throat, congestion, laryngitis, mucous membrane inflammation andsialorrhea. The composition includes ingredients obtainable fromturmeric extract, ginger root powder, and horseradish root powder and isadministered orally to a patient. The composition may further includeingredients obtainable from slippery elm bark powder and green tea aswell as pharmaceutically acceptable carriers for oral administration.

A second reference of Konishi is disclosed in a U.S. Pat. No. 6,541,041for crude drug extracts and methods for making and standardizing same.The extracts contain soluble silicon compounds as an effective componentand are obtained by subjecting a crude drug to extraction with water oran aqueous solvent, preferably at an alkaline pH. The crude drugsubjected to extraction may be derived from animals, plants, etc. Thequality of the crude drug extract can be standardized using the solublesilicon compounds as an index. Those compounds exhibit inhibitory actiontowards the production of plasma kallikrein.

A third disclosure is contained in a U.S. Pat. No. 6,949,260 of Krumharfor a method for treatment of inflammation and pain in mammals. Thecomposition contains effective amounts of a boswellic acid, acurcuminoid, a gingerol, a capsaicinoid, a bioflavonoid, and a vitamin Csource. These compounds are taken from a biotanical source and areblended to form a dose for oral administration. Administration of thedose provides relief from pain and inflammation of connective tissue.The dose may be administered as a tablet, a liquid, or a powder.

An additional disclosure is disclosed in a U.S. Pat. No. 7,282,224 ofRoederer for a pain relief composition. The composition comprises aneffective amount of a never inhibiting component, including capsaicin, acapsaicinoid or a capsaicin analogue, which numbs or inhibits the nerveendings that signal pain. Those compounds are combined with at least oneof the following: an effective amount of inflammation control componentwhich is designed to reduce immediate pain and discourage future pain inthe joints and muscles; an effective amount of a cooling component; aneffective amount of a heat minimizing or blocking component; aneffective amount of a circulation increasing component which effectuatesbetter penetration of the actives to the skin and nerves and aneffective amount of soothing and anti-inflammatory complex for thejoints and/or muscles comprising Glusosamine sulfate or HCl, Zingiberofficiniale (Ginger Root) extract, Methyl sulfonylmethane (MSM),Polygonum cuspidatum (Mexican Bamboo) extract, Alo barbadensis leaf, andSalix alba (white will) bark extract.

A U.S. Patent Application Publication No. 2007/0243270 of Evans et al.discloses methods for reducing cellular damage, inhibiting free radicalproduction and scavenging free radicals in mammals. The methods include(a) administering to the mammal an oral dosage form comprising atherapeutically effective amount of a first antioxidant, and (b)administering to the mammal a topical dosage from comprising atherapeutically effective amount of a second antioxidant, wherein atleast one of the first antioxidant and the second antioxidant comprisesacerola concentrate. Methods of inhibiting free radical production,methods of scavenging free radicals, and kits for reducing cellulardamage are also described.

A still further disclosure is disclosed in a U.S. Patent ApplicationPublication No. 2009/0220625 of Herrmann et al. This publicationdiscloses a synergistic mixture of bisabolol and ginger extract. Theformulation disclosed has a skin irritation reducing action comprisingbisabolol and a composition or compound chosen from the group consistingof a) substance mixtures obtainable from an extraction of ginger, b)substance mixtures obtainable from a separation of a ginger extractwhich comprises a compound which is chosen from the group consisting ofgingerols, shogaols, gingerdiols, dehydrogingerdinoes, paradols andderivatives thereof and c) compounds obtainable from a separation of aginger extract which are chosen from the group consisting of gingerols,shogaols, gingerdiols, dehydrogingerdiones, paradols and derivativesthereof and mixtures thereof, wherein in particular content of bisabololand of the said compositions or compound in the formulation is adjustedsuch that the skin irritation-reducing action is these contents isincreased synergistically.

In addition to the above, a U.S. Pat. No. 7,744,931 of Newmark et al.discloses a method for treating oral cancers with herbal compositions.The method comprises administering a composition comprisingtherapeutically effective amounts of supercritical extracts of rosemary,turmeric, oregano and ginger and therapeutically effective amounts ofhydroalcoholic extracts of holy basil, ginger, turmeric, Scutellariabaicalensis, rosemary, green tea, huzhang, Chinese goldthread, andbarberry. The inventive subject matter further relates to methods formodulating gene expression of genes selected from the group consistingof interleukin-1α, interluekin-1β, heme oxygennase 1, aldo-ketoreductase family 1, member C2, colony stimulating factor 3, leukemiainhibitory factor, heat shock 70 kDa protein, and combinations thereof,by administration of an effective amount of said compositions.

Finally, a U.S. Pat. No. 7,777,073 of Gupta discloses a topical deliverysystem for antiaging and skin whitening agents. As disclosed, a certainhydroxyaryl alkanols, alkyl amines, alkyl amino alkanols (“Hydroxyarylcompounds”) of formula (1). A method of topical application of saidhydroxyaryl compounds is also disclosed. The treatment of certain enzymedysfunctions that cause skin or hair conditions such as darkened skinincluding age spots, dark circles around the eyes, and discoloration ofskin from stretch marks; skin conditions related to acne includingexcess facial oil and facial pore size; premature hair aging includinghair loss and graying; inflammation including intra-cellular andextra-cellular inflammation; skin aging including wrinkles and the finelines; loss of collagen including thinning skin and loss of skinpliability; malfunction of tyrosinase group of enzymes; and malfunctionof matrix metalloprotease group of enzymes with said hydroxyarylcompounds is also disclosed.

Each of the above references is incorporated herein in their entirety byreference.

Notwithstanding the above it is presently believed that there is a needand a potential commercial market for improved compositions and methodsfor the treatment and management of pain in human patients. There shouldbe a commercial market because such compositions and methods have beenshown to produce greater than expected results and a reduction of painin over 72% of respondents who responded completely too somewhat lesspain after using a topical pain relief cream for one to two weeks. Over90% of the respondents reported that completely to somewhat agreed thatthe topical cream was easy to use while 60% said that it was effectivefor pain management and 96% agreed completely that the odor-free benefitwas very important. Further, when probed on continued interest in theproduct 72% agreed that they were interested in using the product beyondthe trial period and almost 60% felt that the product not only exceededtheir expectations, but that they were extremely satisfied with theproduct as well. A survey also indicated customer feedback on theingredients, formulation and field of product.

Overall, respondents like this natural pain relief cream; 70% somewhatto completely agreed that the natural formulation was important to themand 80% agreed with the statement “I like the way the product feels onmy skin”. 100% of respondents agreed that it was important that theproduct was non-greasy and 96% agreed that it was important that thecream had no side effects. Of the entire group, 72% were interested inthe continued use of the product. In addition, a majority of the usersreported pain reduction and 20% indicated a level of 5-6 i.e. moderateto severe pain down from 50% at the start of the trial.

BRIEF SUMMARY OF THE INVENTION

In essence, the present invention contemplates an herbal organiccomposition for the management of pain. The herbal/organic compositioncomprises and/or consists of turmeric extract, Boswellia extract, gingerextract, holy basil extract, rosemary extract, white willow barkextract, alpha lipoic acid and trolamine salicylate and a topicallyacceptable carrier.

In a preferred embodiment of the invention the herbal/organiccomposition consists of about the pharmaceutically acceptable carrierselected from the group consisting of water, glycerol stearate,octinoxate, alphotocapherol (vitamin E), diazolidimylurea, CocoCaprylate/Caprate and Sterearyl Stearate.

A further embodiment a composition for the management of pain accordingto claim 6 in which the turmeric extract has been normalized to compriseabout 95% curcuminoids, the Boswellia extract has been normalized tocomprise about 65% boswellic acid, the ginger extract has beennormalized to comprise about 5% gingerols, the holy basil extract hasbeen normalized to comprise about 2% ursolic acid, the rosemary extract(Rosmarinus officialis) (leaf) is standardized to 6% Carmosic acid, andthe willow bark extract (bark) is standardized to 15% total salicin.

DESCRIPTION OF THE PREFERRED EMBODIMENTS OF THE INVENTION

The present invention relates to compositions and methods for thetreatment and management of pain in a subject. Although herbal extractshave been used for the treatment and management of pain, new and moreeffective formulations for the treatment and management of pain areprovided herein.

As used herein, the term “pain” refers to acute and chronic pain,including pain caused by trauma or inflammation such as back pain,toothache, headache, and menstrual cramps, sore throat, fever, andrheumatic pain such as joint pain, gouty arthritis, ankylosingspondylitis, rheumatoid arthritis, and pain associated with systemicconnective tissue disorders, cancer, neuropathy and referred pain.

As used herein, the term “treatment and management of pain” refers topharmacologic measures that lead to the amelioration of the symptom.Such treatment or management of pain is sufficient to eliminate orsignificantly reduce pain or the effects of pain. More specifically,such pharmacological measures include the administration of the mixturedescribed herein to a subject either topically or orally to ameliorateor relieve pain.

As used herein, “therapeutically effective amount” refers to the amount(dose) of a composition sufficient for the treatment or management ofpain in a subject. Determination of a therapeutically effective amountor dose is determined by one of skill in the art according to thedesired effect, e.g., degree to which pain is treated or managed.

As used herein, the term “subject” refers to an animal, in particular, amammal, e.g., a human.

The components of the compositions of the present invention include, butare not limited to, white willow bark extract, rosemary extract, gingerextract, turmeric extract, Boswellia extract, holy basil extract andalpha lipoic acid. These components can be, for example, normalized to aparticular active compound or compound present within the extract.

Alpha Lipoic Acid

Alpha Lipoic Acid is also called lipoic acid, thioctic acid, or ALA. Itis a fatty acid found naturally inside every cell in the body. Alphalipoic acid converts glucose (blood sugar) into energy.

Alpha lipoic acid is also an antioxidant, a substance that neutralizespotentially harmful chemicals called free radicals. What makes alphalipoic acid unique is that it functions in water and fat, unlike themore common antioxidants vitamins C and B, and it appears to be able torecycle antioxidants such as vitamin C and glutathione after they havebeen used up. Glutathione is an important antioxidant that helps thebody eliminate potentially harmful substances. Alpha lipoic acidincreases the formation of glutathione.

Alpha lipoic acid is made by the body and can be found in very smallamounts in foods such as spinach, broccoli, peas, Brewer's yeast,brussel sprouts, rice bran, and organ meats.

Alpha lipoic acid supplements are available in capsule form at healthfood stores, some drugstores, and online For maximum absorption, thesupplements should be taken on an empty stomach.

Alpha lipoic acid may help treating peripheral neuropathy that can becaused by injury, nutritional deficiencies, chemotherapy or byconditions such as diabetes, Lyme disease, alcoholism, shingles, thyroiddisease, and kidney failure. Alpha lipoic acid is thought to work as anantioxidant in both water and fatty tissue, enabling it to enter allparts of the nerve cell and protect it from damage. The dose that isbest tolerated while still providing benefit is 600 mg, once daily.

Alpha lipoic acid can cross the blood-brain barrier, and pass easilyinto the brain. It is thought to protect brain and nerve tissue bypreventing free radical damage.

As an antioxidant, alpha lipoic acid can neutralize free radicals thatcan damage cells, and helps age-related conditions and chronicillnesses. Alpha lipoic acid has also been suggested for use to treat ormanage cataracts, glaucoma, multiple sclerosis, burning mouth syndrome,Alzheimer' s disease and stroke.

The extracts and alpha lipoic acid can be used as ingredients, forexample, in compositions that can be used to treat or ameliorate pain orconditions associated with pain. Two, three, four, five, six or more ofthe extracts can be used as ingredients in such compositions, with orwithout alpha lipoic acid. Such compositions can also compriseadditional extracts as determinable by one of skill in the art.

Boswellia Extract

Boswellia, known also as Boswellia serrata, is a branching tree that isnative to India. It grows in dry, hilly regions of the country andproduces a resin that can be extracted and purified for medicinalpreparations.

Boswellia extract is best known among herbalists as a treatment forarthritis. One of its primary active ingredients, boswellic acid, is ananti-inflammatory that can be used in ointments to ease joint pain.Boswellia extract can also be taken internally as an anti-inflammatoryagent, much like NSAIDs (non-steroidal anti-inflammatory agents), suchas ibuprofen, which is commonly used to treat pain. However, unlikeNSAIDs, Boswellia extract can be used for significant periods of timewithout causing stomach upset.

Boswellia extract is available in capsules, with extracts standardizedfor boswellic acids. The recommended dosage to treat arthritis is theamount that contains 150 mg of boswellic acids, taken three times perday.

Ginger Extract

Ginger is a tuber that is consumed whole as a delicacy, medicine or usedfor cooking or tea. It is the underground stem of the ginger plant,Zingiber officinale. The medicinal form of ginger historically wascalled “Jamaica ginger”; it was classified as a stimulant andcarminative, and used frequently for dyspepsia and colic. It was alsofrequently employed to disguise the taste of medicines. Ginger is on theFDA's “generally recognized as safe” list, though it does interact withsome medications, including warfarin. Ginger is contraindicated inpeople suffering from gallstones as the herb promotes the release ofbile from the gallbladder. Ginger also decreases joint pain fromarthritis, though studies on this have been inconsistent, and may haveblood thinning and cholesterol lowering properties that may make ituseful for treating heart disease. Ginger and its extract have been usedagainst diarrhea and nausea caused by seasickness, morning sickness andchemotherapy, though ginger was not found superior over a placebo forpost-operative nausea.

Ginerrol, or sometimes [6]-gingerol, is the active constituent of freshginger. Chemically, gingerol is a relative of capsaicin, the compoundthat gives chile peppers their spiciness. It is normally found as apungent yellow oil, but also can form a low-melting crystalline solid.Cooking ginger transforms gingerol into zingerone, which is less pungentand has a spicy-sweet aroma. Gingerol may reduce nausea caused by motionsickness or pregnancy and may also relieve migraine. In the West,powdered dried ginger root is made into capsules and sold in pharmaciesfor medicinal use.

Holy Basil Extract

Holy Basil (Ocimum tenujfiorum or Ocimum sanctum) has been shown topossess powerful adaptogenic properties and has been used to enhance thebody's ability to respond to stress and minimize the negative effects ofstress on the body. Animal studies have demonstrated that holy basil cansupport carbohydrate metabolism and, as a result, healthy blood glucoselevels. Holy basil is revered as a sacred plant in Ayurveda, thetraditional therapeutic system of India.

Studies have shown holy basil leaves have properties similar to theanti-TB drugs like Streptomycin and Isoniazide. Essential oil of holybasil has been used as a potent anti-malarial drug. It also has mosquitorepellent properties. Research has also shown that holy basil acts as ananti-oxidant and decreases stress hormones. It is a powerfulanti-inflammatory similar to aspirin and ibuprofen, but unlike aspirinand ibuprofen it is not irritating to the stomach and in fact, it hasproperties that help to prevent ulcers caused by these drugs.

As an herbal dietary supplement, the extract is standardized to 2%Ursolic Acid and is taken 1-2 times daily, preferably with meals.

Rosemary Extract

Rosemary (Rosmarinus officinalis) and its extract are well-known forfood seasoning and cosmetics. Additionally, rosemary extract has beenused to treat a wide range of ailments. Orally, rosemary is used forupset stomach, digestive disorders and headaches, inducing abortion,increasing menstrual flow, gout, liver and gallbladder complaints, andfor cardiovascular conditions such a high blood pressure. Topically,rosemary is used for preventing baldness, alopecia areata, circulatorydisturbances, toothache, eczema, joint or musculoskeletal pain such asmyalgia, sciatica and intercostal neuralgia, balneotherapy, woundhealing, and as an insect repellent. Rosemary extract also allegedlyhelps prevent cancer and age-related skin damage, boosts the functioningof the liver and acts as a mild diuretic to help reduce swelling.

The applicable part of rosemary is the leaf. The active constituent ofrosemary leaves is the essential oil. Dried leaves contain from 1-2.5%of the essential oil. The oil consists primarily of cineole, bomeol,bomyl acetate, camphor, camphene, pinenes, and a-terpineol. Othercompounds are diterpenes (picrosalvin, carnosolic acid,rosinariquinone), poliphenols: caffeic acid and rosmarinic acid,flavonoids (apigenin, diosmetin, diosmin, genkwanin, hispidulin,sinensetin, luteolin), and triterpenes (ursolic acid). Diterpenoids havebeen shown to be effective to protect biological systems againstoxidative stresses.

Trolamine Salicylate

Trolamine salicylate is an organic compound which is a salt formedbetween triethanolamine and salicylic acid according to Wikipedia, theFree Encyclopedia.

The organic compound is frequently used as an ingredient in sunscreen,creams and cosmetics. Triethanolaminem neutralizes the acidity of thesalicylic acid. Benefits of this topical analgesic is that it has noodor in contrast to topical analgesics such as menthol.

As stated by Wikipedia, one study reported that trolamine salicylatedoes penetrate into, and persists within underlying muscle tissue. Thestudy indicated that individuals using the trolamine salicylate productreported slower onset of soreness, reduced levels of soreness andreduced duration of soreness as compared to those using a placebo.

Turmeric Extract

Turmeric extract is a bright yellow/orange polyphenol having the form ofa dry powder that is fat-soluble. The concentrate has neither flavor noraroma. It colors food readily if there is oil present. The medicinalproperties and health benefits of turmeric extract are attributed partlyto its strong anti-oxidant and anti-inflammatory characteristics.Turmeric extract is derived from the root of the turmeric plant first bydrying and then by separation using a solvent. There are 18 times morecurcuminoids in the concentrate than in the natural spice, which issimply a powdered form of the dried root. The concentrate is also knownas Curcumin

Turmeric extract has attracted the attention of researchers in thefields of Alzheimer's disease, memory deficits, arthritis, cancer(including breast cancer), and diabetes. The plant has the botanicalname of “Curcuma Longa Linn,” and is a member of the Zingiberaceae orginger family. Its source is India but it is now cultivated in China andelsewhere. It grows to one meter in height and has long oblong leaves.Beneath the foliage, in the ground, are the rhizomes from which the foodcoloring is derived. The effect or benefits of turmeric extract are asan anti oxidant, as anti-inflammatory, as anti-dyspepsia, to break upAlzheixner's ainyloid-beta oligomers and aggregates, for itsanti-platelet effects, and to cause apoptosis (death) of variousmalignant cell types including skin, colon, forestomach, duodenum andovary.

Turmeric extract can be obtained with a normalized curcuminoid contentof 95% plus. Customary usage of turmeric extract is about 1-2.5 g perday.

White Willow Bark Extract

The white willow bark extract can be used as an analgesic andantipyretic for the treatment of pain and inflammation. An activeconstituent of the extract is salicin, an anti-inflammatory agent thatis produced from all willow barks. Salicin is an alcoholic β-glycosidethat contains glucose. Salicin is closely related in chemical makeup toaspirin and has a similar action in the human body. When consumed, it ismetabolized to salicylic acid.

Although active agents present in extracts can be purified and used,complications and impurities associated with synthesis and/orpurification of the purified active agents make purified active agentsundesirable. The use of extracts as described herein, allows for thesafe administration of naturally occurring compositions. In addition,extracts contain a combination of other compounds that can also havetherapeutic or ameliorative benefits.

Obtaining extracts from natural sources leads to variability ofcomposition from batch to batch. As such, the extracts described hereincan be normalized such that the extract contains a certain percentage ofa particular compound, e.g., an active agent. Boswellia extract, forexample, can be normalized to comprise about 50% to about 95% boswellicacids, about 60% to about 80% boswellic acids, about 65% boswellicacids, about 70% boswellic acids, or any normalized percentage suitablefor use in the compositions described herein. Ginger extract, forexample, can be normalized to comprise about 0.5% to about 10%gingerols, about 0.25% to about 8% gingerols, about 1% gingerols, about2% gingerols, or any normalized percentage suitable for use in thecompositions described herein.

Holy basil extract, for example, can be normalized to comprise about0.5% to about 20% ursolic acid, about 1% to about 10% ursolic acid,about 2% ursolic acid, about 1% ursolic acid, or any normalizedpercentage suitable for use in the compositions described herein.Rosemary extract, for example, can be normalized to comprise about 5% toabout 40% diterpenes, about 10% to about 30% diterpenes, about 20%diterpenes, about 25% diterpenes, or any normalized percentage suitablefor use in the compositions described herein. Willow extract, forexample, can be normalized to comprise about 2% to about 35% salicin,about 5% to about 20% salicin, about 15% salicin, about 20% salicin, orany normalized percentage suitable for use in the compositions describedherein.

Compositions described herein contain a therapeutically effective amountof six extracts and lipoic acid. One of skill in the art would be ableto determine a therapeutically effective dose. A normalized extract, forexample, can comprise about 0.01%, about 0.5%, 1.0%, 2.5%, 5% orgreater, of the therapeutic compositions described herein.

Compositions described herein can comprise, for example, ingredientsthat aid in the delivery and/or preservation of the active agents.Compositions can comprise, for example, excipients,pharmaceutically-acceptable carriers, preservatives and/or deliveryagents/vehicles. An excipient is an inactive substance used as a carrierfor the active ingredients of a medication. In some cases, an activesubstance may not be easily administered and absorbed by the human body.In such cases the substance in question can be mixed with an excipient.

Excipients can also be used to bulk up formulations that contain verypotent active ingredients, to allow for convenient and accurate dosage.In addition to their use in the single dosage quantity, excipients canbe used in the manufacturing process to aid in the handling of theactive substance concerned. Depending on the route of administration,and form of medication, different excipients may be used, as determinedby one of skill in the art.

Pharmaceutically-acceptable carriers can include, for example, creamsand compositions that allow for the diffusion or active transport ofactive agents across the skin for use in, for example, compositions thatare to be administered topically. Alternatively, carriers can be suitedto oral administration, for example, by allowing diffusion of activeagents from capsules or tablets. Such carriers are known to those ofskill in the art and can be selected according to the mode ofadministration.

The compositions of the present invention can be administered in anypharmaceutically-acceptable manner. Compositions for topical and oraladministration are described, however the compositions described hereincan also be administered, for example, rectally, intravenously orsubcutaneously using, for example, an implantable device.

EXAMPLES Example 1 Background:

A clinical comparison study was conducted to test the efficacy of atopical herbal medication for inflammatory and chronic pain relief inadults over the age of 18. The participants tested the products over a7-day period and then evaluated them for the efficacy of the herbalmedication through pre and post study questionnaires. Conclusions weredrawn based on the responses of the participants regarding pain reliefat the end of the 7-day period.

Subject Selection:

Subjects included adults (age 18 years or older) able to provide writteninformed consent for study participation and able to fully participatein this study. The study did not intend to examine chronic orinflammatory joint pain reduction in any specific race or ethnicity orgender, therefore subjects included any race/ethnicity. Subjects whohave inflammatory joint pain due to Rheumatoid Arthritis, and/or otherinflammatory conditions, chronic muscle pain and spasms, and neuropathicjoint pain due to diabetes were considered for the study. The study didnot include any participants who were pregnant, had been diagnosed ofpsychiatric disorders, brain disorders or showed an inability tocommunicate. Subjects with medical condition that contradicted the useof herbal medications were not included in the study. Questionnaires toevaluate pain were given to the subjects prior to the start, and the endof the study to evaluate pain relief.

The subjects were recruited from all races/ethnicities to the extentpossible. Participants were recruited from across the Washington, D.C.,Maryland and Virginia area, and were afflicted by chronic andinflammatory joint pain, chronic muscle pains and spasms. The study madeevery attempt to assure adequate representation of each minority/ethnicgroup. A total of 50 subjects were recruited for the study, with 25participants being used in a control group, and 25 in a treatment group.

Procedures:

The subjects were divided into treatment and control groups by randomassignment, and given a consent form and a 7-day supply of the topicalproduct. Subjects were instructed to apply the topical cream 3-4 timesdaily (at the site of pain) for the 7-day period. Instructions on theuse of the medications were provided at the start of the study, and theparticipants agreed not to let anyone else use the product. Theyassessed their pain through questionnaires in English on two occasions;at the start of the study, and at the end of the study. Thequestionnaires required about 10-15 minutes to complete while the timefor using the medications was minimal, about the time required to applyan ointment. No participant was paid, or received any sort ofcompensation, for agreeing to participate in this study.

Consent Forms and Information

Subjects were included as part of the study only after they read andunderstood the informed consent form, which was available in Englishonly. The subjects were informed about the objective of the study—toevaluate the efficacy of a newly formulated herbal medication to relievechronic and inflammatory joint pain. Instructions to use the medicationswere provided separately to the group and subjects were informed of therisks involved in improper use of the medication, and given writteninstructions on using the products. The informed consent forms wererequired to be read and signed personally by the subjects before beingincluded in the study.

Survey

A pre and post study survey was created to gather participant feedbackon the all natural pain-relief cream created to treat chronic andinflammatory joint pain. The pre study questionnaire probed the level ofpain each participant experienced through a variety of questionsdesigned to capture as much information as possible on the type of pain,location, and severity. The post study questionnaire asked participantsto rate their pain experience after having used the topical pain reliefcream, and was designed to capture information on type of pain reliefexperienced, and perceptions and intent towards the topical pain creamafter having used it for the 7-day period.

Results—Treatment Group

To create a benchmark for the effectiveness of the cream, participantswere asked to rate their current type and level of pain on day one ofthe study. (The control group reflected the treatment group to the typeand level of pain, and there was no relevant or statistical change tothe type or frequency of pain for the control group over the 7-dayperiod, and these results reflect responses from the 25 participants inthe treatment group.)

Three different types of pain were assessed in the study: chronic,muscular or nerve and of these three types, over 68% percent ofrespondents described their pain as muscular.

Muscular pain included acute muscle aches from a sporting injury, painfrom conditions such as fibromyalgia or cancer treatments, and involvedligaments, tendons, bones and organs. Chronic or acute pain andinflammation, which included side-effects like burning or swelling,accounted for over 48% of respondents, while 20% reported their pain asnerve pain—burning, throbbing or stinging.

Participants were also asked to rate their level of pain at the start ofthe study survey. On a scale of 1-10 (with 1 being no pain, and 10 beingunbearable pain), over half rated their pain level at a 5-6; moderate tosevere pain that was discomforting and distressing. None of therespondents indicated any pain, or unbearable pain, and mild to moderatepain was the next highest reporting group at 24%.

After using the product for seven days, respondents were again asked toassess their level of pain and inflammation, as well as their opinionson the efficacy and formulation of the natural pain relief cream. By dayseven, when asked, “I feel like I have less pain”, over 72% ofrespondents completely too somewhat agreed that their level of pain wasreduced after using the topical pain relief cream. In addition, nearly60% of users reported a reduction in inflammation. Respondents were alsoasked a series of questions about the mechanics of using the cream. Over90% of respondents completely to somewhat agreed that the topical creamwas easy to use. Nearly 60% felt the cream was effective for painmanagement and 96% agreed completely that the odor-free benefit was veryimportant. When probed on continued interest in the product, 72% agreedthey were interested in using the product beyond the trial period, andalmost 60% felt the product not only exceeded their expectations, butthat they were extremely satisfied with the product, as well.

The survey also captured consumer feedback on the ingredients,formulation, and feel of the product. Overall, respondents liked thisnatural pain relief cream. 72% somewhat to completely agreed that thenatural formulation was important to them, and 80% agreed with thestatement, “I like the way the product feels on my skin”. 100% ofrespondents agreed that it was important the product was non-greasy, and96% agreed that was important the cream had no side-effects. Of theentire group, 72% were interested in continued use of this product. Whenasked again to assess their level of pain on a scale of 1-10 (1 beingzero pain and 10 being unbearable pain), the majority of uses reportedpain at a level 2-3, little to mild pain. Even more important, only 20%indicating a level 5-6, moderate to severe pain—down from 50% at thestart of the trial.

Conclusions

While at the start of the study, over 50% of participants rated theirpain as moderate to severe, by day seven, 72% of users reported areduction in their level of pain, and 56% reduction in inflammation. Atthe end of the survey, only 20% of participants rated their pain asmoderate to severe, and 48% indicated they have very little to no painImportantly, 92% of users felt the product was easy to use, 80% ofparticipants liked the way the product felt on the skin, and 100% ofusers felt the non-greasy texture of the cream was important.

Overall, participants were interested in the product, liked theformulation and ease of use, and felt (and noticed) a reduction in theirlevel of pain. The all-natural ingredient profile, the fact that theproduct had no odor, and didn't leave the skin feeling greasy were allextremely important benefits to the users, indicating that for painsufferers, aesthetics are just as important as esthetics when it comesto treating their pain. According to the participants' comments, theydon't want a perfunctory, mundane treatment they want a solution thatwill also appeal to their senses and fit in with their lifestyle. Theother benefit that was extremely important to participants, the factthat the cream had no side-effects—further supports the idea that atopical pain relief cream must answer more than just the question ofpain, it should take into account overall health, as well.

Perhaps due to unsatisfactory experiences with other topical pain reliefcreams, participants in this study were surprised to find the productexceeded their expectations.

Accordingly, interest in continued use of the product was high, as wasthe inclination to recommend the product to others. Taking into accountthe fact that, overall, users reported a reduction in their the level ofpain, as well as the user benefits and high continued-interest in theproduct, the data suggests that the topical pain cream of the presentinvention meets a need in the art that is not currently being met.

Example 2 Background and Purpose

Patients with muscle and joint dysfunction often experience waxing andwaning episodes of inflammation. The purpose of this study was toevaluate the efficacy of the topical herbal formulation of the presentinvention in assisting patients with management of these episodes.

Study Description

A total of 30 subjects with a variety of musculoskeletal diagnoses werechosen for the study. The diagnoses included: cervical strain, lumbarstrain, knee sprain, shoulder sprain, knee osteoarthritis, handosteoarthritis and tendinitis of the knee, elbow and shoulder. Allsubjects received an initial week of therapy without the use of thetopical herbal formulation. Pain and irritation was evaluated at thestart of treatment and at the end of the initial week using the visualanalog scale (VAS). Following the initial week of therapy, no changeswere made in the plan of care except for the addition of the topicalherbal formulation, which was used during each treatment for a period oftwo weeks. Each subject was also given a tube for use at home. Subjectswere instructed to apply liberally 2-3 times per day for a period of twoweeks. Return demonstration was required by each subject to ensureproper application. Pain assessments were performed weekly using theVAS. The results are shown in Table I below:

TABLE 1 Subject Diagnosis Pain at Trial Start Pain at Trial EndPercentage Change 1 Tennis elbow 7 3 57% 2 MCL sprain 5 2 60% 3 Lumbarstrain 6 4 33% 4 Shoulder strain 4 0 100%  5 Cervical strain 6 2 67% 6Cervical strain 6 3 50% 7 Knee osteoarthritis 7 1 86% 8 Wristosteoarthritis 8 4 50% 9 Lumbar strain 7 7 No change 10 Kneeosteoarthritis 8 Returned cream — 11 Cervical strain 5 2 60% 12 Footpain 4 4 No change 13 Shoulder strain 6 3 50% 14 Patella tendonitis 4 175% 15 Achilles tendonitis 5 5 No change 16 Biceps tendonitis 8 7 13% 17Lumbar strain 8 5 38% 18 Cervical strain 7 2 71% 19 Hand osteoarthritis5 4 20% 20 ACL sprain 6 2 67% 21 Medial epicondylitis 7 6 14% 22 Tenniselbow 5 2 60% 23 Biceps tendonitis 4 1 75% 24 Knee osteoarthritis 7 443% 25 Wrist osteoarthritis 7 3 57% 26 Lumbar strain 6 5 17% 27 Patellatendonitis 4 1 75% 28 Rotator cuff tendonitis 6 2 67% 29 Cervical strain9 6 33% 30 MCL sprain 7 5 29%

Results

A total of 60% of the patients had a 50% or more reduction in painduring the 2-week 5 trial, while 90% of the patients had some reductionin pain during the 2-week trial. Only one patient returned the cream andrefused to continue with the study and only three patients had nochange.

CONCLUSION

The data suggests that the herbal formulation of the present inventionis useful for reducing musculoskeletal pain and inflammation.

While the invention has been described in connection with its preferredembodiment it should be recognized that changes and modifications may bemade therein without departing from the scope of the appended claims.

What is claimed is:
 1. An herbal/organic composition for the managementof pain comprising turmeric extract, Boswellia extract, ginger extract,holy basil extract, rosemary extract, white willow extract, alpha lipoicacid and trolamine salicylate and a topically acceptable carrier.
 2. Anherbal/organic composition for the management of pain according to claim1, which contains about 0.01 wgt % turmeric extract, about 0.01 wgt %Boswellia extract, about 0.01 wgt % ginger extract, about 0.01 wgt %holy basil extract, about 0.01 wgt % rosemary extract, about 0.01 wgt %white willow extract, about 0.01 wgt % alpha lipoic acid and about 10.0wgt % trolamine salicylate and about 89.93 wgt % of an acceptabletopical carrier.
 3. An herbal/organic composition for the management ofpain according to claim 2, in which said topical carrier is from thegroup consisting of water, glycerol stearate, octinoxate,alphotocapherol (vitamin E), diazolidimylurea, Coco Caprylate/Caprateand Sterearyl Stearate and mixtures thereof.
 4. An herbal/organiccomposition for the management of pain according to claim 3, in whichsaid acceptable topical carrier is water.
 5. An herbal/organiccomposition for the management of pain consisting of 0.01 wgt % turmericextract, 0.01 wgt % Boswellia extract, 0.01 wgt % ginger extract, 0.01wgt % holy basil extract, 0.01 wgt % rosemary extract, 0.01 wgt % whitewillow extract, 0.01 wgt % alpha lipoic acid and 10.0 wgt % trolaminesalicylate and 89.93 wgt % water.
 6. A method for treating pain in ahuman subject comprising administering a therapeutic effective amount ofthe composition of claim
 5. 7. A method for treating pain in a humansubject according to claim 6, in which said administration of atherapeutic effective amount of the composition is repeated three orfour times a day.
 8. A method for treating pain in a human subjectaccording to claim 7, in which said administration of therapeuticeffective amounts of said composition is repeated for seven days to 14days.